FDA approves test to detect genetic markers for resistant bacteria

The Food and Drug Administration approved the Xpert Carba-R Assay, a test that can analyze patient specimens to detect specific genetic markers associated with bacteria resistant to carbapenem antibiotics, which are commonly used in hospitals to treat severe infections.

The Xpert Carba-R Assay, developed by Sunnyvale, Calif.-based Cepheid, is intended to serve as an aid in infection control. The tool tests for the most prevalent genes associated with resistance to the carbapenem antibiotics, but does not detect the bacteria itself or other possible causes of carbapenem resistance.

Current methods to identify the resistant organisms entail growing bacteria from fecal material in cultures and then subjecting the samples to antimicrobial susceptibility testing, a process that can take up to four days.

"By using a specimen taken directly from a patient to test for the presence of genetic markers, hospitals can more quickly identify these dangerous bacteria resistant to certain antibiotics," said Alberto Gutierrez, MD, director of the FDA's Office of In Vitro Diagnostics and Radiological Health.

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